European Medicines Agency
EU Regulator Determines Mounjaro Effective for Sleep Apnea, No Separate Approval Required
Mounjaro, sleep apnea, EU regulator, European Medicines Agency (EMA), tirzepatide, weight loss, obesity
Novo Nordisk’s Alhemo Nears EU Approval: A Breakthrough in Haemophilia Treatment
Novo Nordisk, Alhemo, Haemophilia A and B, Inhibitors, European Medicines Agency (EMA), CHMP positive opinion, Subcutaneous prophylactic treatment, Concizumab
Translarna by PTC Therapeutics: Awaiting Another EU Regulatory Review for Muscular Dystrophy Treatment
PTC Therapeutics, Translarna, muscular dystrophy, EU review, regulatory approval, Duchenne muscular dystrophy (DMD), European Medicines Agency (EMA), ataluren, rare disease treatment.
EMA Recommends Halt on Preterm Birth Medications Due to Safety Concerns
European Medicines Agency (EMA), safety committee, preterm birth drugs, suspension, safety concerns, pregnancy, fetal development.
Europe Temporarily Halts AstraZeneca’s Vaxzevria COVID-19 Vaccine on Company’s Request
AstraZeneca, Vaxzevria, COVID-19 vaccine, marketing authorization, suspension, Europe, European Medicines Agency (EMA), pharmacovigilance, safety concerns.
EU Regulators Confirm No Link Between GLP-1 Drugs and Suicidal Thoughts
GLP-1 drugs, Ozempic, Wegovy, European Medicines Agency (EMA), No link to suicidal thoughts, Investigation
EU Approves Novo Nordisk’s Groundbreaking Once-Weekly Basal Insulin Icodec for Adults with Diabetes
Novo Nordisk, Once-Weekly Insulin Shot, Awiqli, Insulin Icodec, European Medicines Agency (EMA), CHMP Positive Opinion, Type 1 & Type 2 Diabetes Treatment